510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K861401Substantially Equivalent

Laerdal Pocket Mask

Laerdal Medical a/S, Armonk NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861401 is the FDA 510(k) clearance record for LAERDAL POCKET MASK, a class II device, cleared for Laerdal Medical Corp. on under FDA product code CBP (Valve, Non-Rebreathing). FDA records list 20 510(k) clearances for Laerdal Medical Corp., from to . As of , FDA records show no recalls naming K861401.

Clearance record

Decision date
Received
(36 days to decision)
Product code
CBP Valve, Non-Rebreathing
Regulation
21 CFR 868.5870
Device class
Class II
Review panel
Anesthesiology
Applicant
Laerdal Medical Corp. P.O. Box 190, One Labriola Ct., Armonk NY
Third party review
No

Clearances, product code CBP

Trailing 12 months

FDA records hold no clearances under product code CBP in the trailing twelve months.

FDA records show no clearances under product code CBP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260